A Study Of Mircera In Patients With Kidney Disease Who Are Not On Dialysis

Mircera In Patients With CKD Stages III-IV Not On Dialysis: Observational, Non-interventional Cohort Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02490514

Enrollment

153

Registered

2015-07-03

Start date

2009-12-31

Completion date

2012-02-29

Last updated

2015-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Tubular Acidosis, Distal, With Hemolytic Anemia

Brief summary

This open-label, non-randomized, retrospective-prospective, non-interventional study will evaluate the efficacy and safety of Mircera in patients with stage III-IV chronic kidney disease (CKD) not on dialysis. Patients will receive open-label treatment with Mircera for 12 months at a dose to be determined by the investigator.

Interventions

OTHERNo intervention

No intervention was administered in this study.

Study design

Observational model

COHORT

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Patients with stage II-IV CKD not on dialysis, including renal transplant patients, who are receiving erythropoiesis-stimulating agent (ESA) treatment or are ESA-naive * Patients who will not require dialysis within 12 months after the start of Mircera therapy * Patients whose life expectancy is greater than 12 months after Mircera initiation * Patients \>/= 18 years and \</= 75 years of age * Patients who are female and of childbearing potential must be using effective contraception methods * Patients with no contra-indications to ESA treatment (for example, hypersensitivity, non-controlled hypertension and others according to the local SmPC) * Patients who have given written informed consent where local regulations allow or require it

Exclusion criteria

* Patients with stage I-II or stage V CKD * Poorly controlled hypertension * Active malignant disease

Design outcomes

Primary

Measure	Time frame
Percent Of Participants Who Reached And Maintained Target Hemoglobin Values During Treatment	12 months

Secondary

Measure	Time frame
Hb Levels At Start And End Of Treatment	12 months
Mircera Dose At Start And End Of Treatment	12 months
Time To Achieve Response To Mircera	12 months
Percent Of Participants Treated With Iron Supplements	12 months
Percent of Participants Who Required Transfusion At Start And End Of Treatment	12 months

Countries

Serbia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026